study evaluating the safety and efficacy of fixed-dose once-daily oral aripiprazole in children and adolescents with tourette's disorder

Conditions: Tourette's Disorder; Tic Disorder

Summary: the goal of the current trial is to determine efficacy and safety of once-daily aripiprazole in reducing total tic severity in children and adolescents with tourette's disorder.

tourette's disorder is a neuropsychiatric condition that is characterized by the appearance of tics that can be simple or complex in nature. a tic is a sudden, rapid, recurrent, non-rhythmic, stereotyped motor movement or vocalization. there are a very limited number of medications approved for the treatment of tourette's disorder. the goal of the current trial is to obtain efficacy, safety, and tolerability data in a controlled condition of a once-daily aripiprazole formulation in children and adolescents with tourette's disorder. the trial has an 8-week long double-blind treatment period after a pretreatment (screening/washout phase), and the subjects will be followed up for 1 month after the last treatment. the once-daily tablet formulation that will be evaluated in this trial represents a daily dosage regimen that is intended to be administered to children and adolescents.

Eligibility criteria:
inclusion criteria: * male or female, 7 to 17 year old (inclusive) at the time of signing consent * meets dsm-iv-tr diagnostic criteria for tourette's disorder * presenting tic symptoms cause impairment in the subject's normal routines, which include academic achievement, occupational functioning, social activities, and/or relationships * females of childbearing potential must have a negative pregnancy test, must be practicing acceptable double-barrier methods of contraception and must not be pregnant or lactating * written informed consent obtained from a legally acceptable representative \& informed assent at screening as applicable by trial center's irb/iec * the subject, designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator exclusion criteria: * clinical presentation and/or history, consistent with another neurologic condition that may have accompanying abnormal movements * history of schizophrenia, bipolar disorder, or other psychotic disorder * subject receiving psychostimulants for treatment of add/adhd and who have developed and/or had exacerbations of tic disorder after initiation of stimulant treatment * currently meets dsm-iv-tr criteria for a primary mood disorder * severe obsessive compulsive disorder (ocd) * taken aripiprazole within 30 days of the screening visit * received any investigational agent in a clinical trial within 30 days prior to screening, enrolled in studies 31-12-272, 31-12-273, 31-12-274; or who were randomized into a clinical trial with once-daily aripiprazole at any time * history of neuroleptic malignant syndrome * sexually active patients not using 2 approved methods of contraception * females breastfeeding or pregnant (positive blood pregnancy test prior to receiving trial drug) * risk of committing suicide * body weight lower than 16 kg * taken neuroleptic or antiparkinson drugs \< 14 days prior to randomization * requiring cognitive behavioral therapy (cbt) for tourette's during trial * subject meets dsm-iv-tr criteria for any significant psychoactive substance use disorder within the past 3 months * positive drug screen * subject requires medications not allowed per protocol * use of cyp2d6 and cyp3a4 inhibitors or cyp3a4 inducers within 14 days prior to dosing and for duration of trial * use of herbal medications of any kind and nutritional or dietary supplements for tourette's disorder within 7 days prior to dosing and for the duration of the trial * inability to swallow tablets or tolerate oral medication * abnormal laboratory test results, vital signs and ecg results

Keywords: tourette syndrome basal ganglia diseases brain diseases central nervous system diseases tic disorders tics movement disorders mental disorders aripiprazole